Child DevelopmentWASH-BFUNCT04443855
WASH Benefits Child Development Follow up
A study testing Water quality, Sanitation and Hand washing in people with Child Development and Maternal Depression, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial summary
The purpose of this study is to determine if the effects of individual and combined water, sanitation, hygiene, and nutrition interventions in early childhood on child development and maternal mental health persist into middle childhood. Read more about this study
- Who is it for?
- Ages 5 to 7 years
- Conditions the study is for
- Child Development, Maternal Depression
- What is being tested?
- Water quality, Sanitation and Hand washing
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,932 participants
- Where
- 1 siteBangladesh
- Study dates
- 24 Sep 2019to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Enrolled in the wash-benefits Bangladesh intervention
Who cannot join
- No Exclusion criteria
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site, 1 recruiting
- Recruiting
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, 1212
Mahbubur Rahman, MD, +880-2-9827001-10 ext. 4003, mahbubr@icddrb.org
About this study
Official title: Measuring the Effect of WASH Benefits Interventions on Child Development Outcomes at School Age: Follow up of an Efficacy Trial in Rural Bangladesh
The purpose of this study is to determine if the effects of individual and combined water, sanitation, hygiene, and nutrition interventions in early childhood on child development and maternal mental health persist into middle childhood. This study is a follow-up assessment of the children and mothers enrolled in the WASH-Benefits Bangladesh study.
Read the detailed description
Globally, millions of children experience delays in physical health and cognitive development, due to their exposures to poverty and related issues. In low-and middle-income countries, children experience a dis-proportionally high burden of exposure to poverty and related risk factors for delayed development including of poor health and nutrition, inadequate responsive care giving, and a lack of opportunities for early learning. Water, sanitation and hygiene (WASH) interventions have the potential to positively affect the developmental trajectories of children by reducing enteric pathogen infection, improving child health, and altering parental care practices. A recent cluster-randomized controlled trial (cRCT) in Bangladesh (WASH-Benefits, or WASH-B, Clinical Trials.gov Identifier: NCT01590095), found that improvements in WASH or nutrition supported by intensive interpersonal communication, when delivered either individually or in combination, contributed to improvements in child development outcomes at 1 and 2 years of age, and mothers in all intervention groups reported lower depressive symptoms than mothers in the control households.
This follow-up study, funded by the Bill \& Melinda Gates foundation, includes assessments of the children and caregivers originally enrolled in the WASH Benefits intervention 5 years following intervention completion, when the children are 5-8 year of age. The original WASH Benefits intervention enrolled pregnant women between May 31, 2012, and July 7, 2013. The goal of this follow-up study is to examine whether the improvements in child development and maternal mental health are sustained when the children are in middle childhood. Our guiding hypothesis is that interventions that showed early impact will continue to improve child and maternal outcomes at this follow-up time period. Investigators will attempt to collect follow-up data from every household originally randomized to one of the 7 arms in the WASH Benefits trial.
- Conditions
- Child Development, Maternal Depression
- Being tested
- Water quality, Sanitation, Hand washing, Water quality, Sanitation, Hand washing (Combined WASH), Nutrition
- Keywords
- Child Development, WASH, Nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water qualityBehavioural
Hardware: Free supplies chlorine tablets (Aquatabs; NaDCC) and a safe storage vessel to treat and store drinking water.
Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on the treatment of all drinking water for children < 36 months of age.
SanitationBehavioural
Hardware: Free child potties, sani-scoop hoes to remove feces from household environments, latrine upgrades to a dual pit latrine Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on the use of latrines for defecation and the removal of human and animal feces from the compound.
Hand washingBehavioural
Hardware: Hand washing stations, soapy water bottles located at hand washing locations, detergent soap to supply soapy water bottles.
Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on hand washing with soap at critical times around food preparation, defecation, and contact with feces.
Water quality, Sanitation, Hand washing (Combined WASH)Behavioural
Hardware: Free supplies Aquatabs; (NaDCC) and a safe storage vessel to treat and store drinking water. Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on the treatment of drinking water for children < 36 months.
Hardware: Free child potties, sani-scoop hoes to remove feces from household environments, latrine upgrades to a dual pit latrine. Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on the use of latrines for defecation and the removal of human and animal feces from the compound.
Hardware: Hand washing stations, soapy water bottles, detergent soap to supply soapy water bottles. Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on hand washing with soap at critical times as food preparation, defecation, and contact with feces.
NutritionBehavioural
Supplement: Lipid-based Nutrient Supplement (LNS) delivered daily from ages 6 to 24 months.
Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages modeled on those recommended in the Guiding Principles for Complementary Feeding of the Breastfed Child and the recent UNICEF Program Guide for Infant and Young Child Feeding Practices.General messages will include (1) practice exclusive breastfeeding from birth to 6 months of age and introduce complementary foods at 6 months of age while continuing to breastfeed; (2) continue breast feeding as you did before receiving LNS; (3) provide your child micronutrient-rich foods such as meat, fish, eggs, and vitamin A rich fruits and vegetables; and (4) feed your child at least 2-3 times per day when 6-8 months old and 3-4 times per day when 9-24 months old.
Nutrition, Water quality, Sanitation, Hand washingBehavioural
Each of the interventions described above for Water Quality, Sanitation \& Hand washing (Combined WASH) Plus the intervention described above for nutrition.
| Study group | Role | What they receive |
|---|---|---|
| Water quality | Active comparator | 90 clusters, approx. 720 newborns Receives: Behavioral: Water quality |
| Sanitation | Active comparator | 90 clusters, approx. 720 newborns Receives: Behavioral: Sanitation |
| Hand washing | Active comparator | 90 clusters, approx. 720 newborns Receives: Behavioral: Hand washing |
| Combined WASH | Active comparator | 90 clusters, approx. 720 newborns Receives: Behavioral: Water quality, Sanitation, Hand washing (Combined WASH) |
| Nutrition | Active comparator | 90 clusters, approx. 720 newborns Receives: Behavioral: Nutrition |
| Nutrition+ Combined WASH | Active comparator | 90 clusters, approx. 720 newborns Receives: Behavioral: Nutrition, Water quality, Sanitation, Hand washing |
| Non-intervention | No intervention | 180 clusters, approx. 1,440 newborns |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weschler Primary and Preschool Scales of Development 4th edition (WPPSI-IV)
The WPPSI-IV assessment measures cognitive development and general intellectual abilities in children 2 years 6 months to 7 years 7 months of age (2:6-7:7), and includes assessments of both performance and verbal skills.
Measured: 5 years after intervention completion
Executive Functioning
This executive functioning assessment consists of three sub-scales to assess executive functioning in children including verbal memory, visual and non-verbal memory, and memory capacity.
Measured: 5 years after intervention completion
Child Socioemotional Development
Maternal-report questionnaire designed to measure psychological adjustment in children and aims to detect any emotional or behavioural problems.
Measured: 5 years after intervention completion
Fine Motor Development
Manual Dexterity component of Movement Assessment Battery for Children-2 (MABC-2) is a direct assessment tool used to measure fine motor skills in children 3 to 17 years of age.
Measured: 5 years after intervention completion
Academic achievement
The Wide Range Assessment Test (WRAT) assessment is a written and verbal assessment of reading, writing, and math achievement.
Measured: 5 years after intervention completion
Secondary outcomes (5)
Maternal Mental Health
Center for Epidemiologic Studies Depression Scale (20 questions). This scale contains 20 questions asking about the number of days in the past week the respondent has experienced each of the symptoms.
Measured: 5 years after intervention completion
Home environment
The middle childhood HOME includes caregiver report and observational items to assess the quality and quantity of stimulation and support available to the child at home.
Measured: 5 years after intervention completion
School attendance
Parental report
Measured: 5 years after intervention completion
Height-for-Age Z-scores
Child's standing height, standardized to Z-scores using the WHO 2006 growth standards
Measured: 5 years after intervention completion
Weight-for-Height Z-scores
Child's weight and height, standardized to Weight-for-Height Z-scores using the WHO 2006 growth standards
Measured: 5 years after intervention completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start24 Sep 2019
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 4,932 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, University of California, Berkeley
- Responsible party
- Sponsor
- Investigators
- Mahbubur Rahman, MD, Principal investigator, International Centre for Diarrhoeal Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04443855
- Sponsor's protocol ID
- PR-19025
- Acronym
- WASH-BFU
- Status last verified
- Feb 2022
- First submitted
- 30 Apr 2020
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will follow as per icddr,b data sharing policy
Publications
Tofail F, Pitchik HO, Islam M, Khan R, Shoab AK, Akter F, Aktar S, Huda TMN, Rahman M, Winch PJ, Luby SP, Fernald LCH. Effects of early water, sanitation, handwashing, and nutrition interventions on child development at school age: a follow-on study of a cluster-randomized trial in rural Bangladesh. PLoS Med. 2025 Dec 16;22(12):e1004793. doi: 10.1371/journal.pmed.1004793. eCollection 2025 Dec.
PubMed 41401135
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Effect of WASH Benefits Interventions on Child Development Outcomes at School Age: Follow up of an Efficacy Trial in Rural Bangladesh
- ClinicalTrials.gov ID
- NCT04443855
- Acronym / sponsor ID
- WASH-BFU / PR-19025
- Conditions
- Child Development, Maternal Depression
- Keywords
- Child Development, WASH, Nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,932 participants (estimated)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Collaborators
- Stanford University, University of California, Berkeley
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 23 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if the effects of individual and combined water, sanitation, hygiene, and nutrition interventions in early childhood on child development and maternal mental health persist into middle childhood. This study is a follow-up assessment of the children and mothers enrolled in the WASH-Benefits Bangladesh study.
Detailed description
Globally, millions of children experience delays in physical health and cognitive development, due to their exposures to poverty and related issues. In low-and middle-income countries, children experience a dis-proportionally high burden of exposure to poverty and related risk factors for delayed development including of poor health and nutrition, inadequate responsive care giving, and a lack of opportunities for early learning. Water, sanitation and hygiene (WASH) interventions have the potential to positively affect the developmental trajectories of children by reducing enteric pathogen infection, improving child health, and altering parental care practices. A recent cluster-randomized controlled trial (cRCT) in Bangladesh (WASH-Benefits, or WASH-B, Clinical Trials.gov Identifier: NCT01590095), found that improvements in WASH or nutrition supported by intensive interpersonal communication, when delivered either individually or in combination, contributed to improvements in child development outcomes at 1 and 2 years of age, and mothers in all intervention groups reported lower depressive symptoms than mothers in the control households.
This follow-up study, funded by the Bill \& Melinda Gates foundation, includes assessments of the children and caregivers originally enrolled in the WASH Benefits intervention 5 years following intervention completion, when the children are 5-8 year of age. The original WASH Benefits intervention enrolled pregnant women between May 31, 2012, and July 7, 2013. The goal of this follow-up study is to examine whether the improvements in child development and maternal mental health are sustained when the children are in middle childhood. Our guiding hypothesis is that interventions that showed early impact will continue to improve child and maternal outcomes at this follow-up time period. Investigators will attempt to collect follow-up data from every household originally randomized to one of the 7 arms in the WASH Benefits trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Water quality | Active comparator | Behavioral: Water quality90 clusters, approx. 720 newborns |
| Sanitation | Active comparator | Behavioral: Sanitation90 clusters, approx. 720 newborns |
| Hand washing | Active comparator | Behavioral: Hand washing90 clusters, approx. 720 newborns |
| Combined WASH | Active comparator | Behavioral: Water quality, Sanitation, Hand washing (Combined WASH)90 clusters, approx. 720 newborns |
| Nutrition | Active comparator | Behavioral: Nutrition90 clusters, approx. 720 newborns |
| Nutrition+ Combined WASH | Active comparator | Behavioral: Nutrition, Water quality, Sanitation, Hand washing90 clusters, approx. 720 newborns |
| Non-intervention | No intervention | –180 clusters, approx. 1,440 newborns |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Enrolled in the wash-benefits Bangladesh intervention
Key exclusion criteria (1 listed)
- No Exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water qualityHardware: Free supplies chlorine tablets (Aquatabs; NaDCC) and a safe storage vessel to treat and store drinking water. Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on the treatment of all drinking water for children < 36 months of age. | Behavioural | Water quality |
| SanitationHardware: Free child potties, sani-scoop hoes to remove feces from household environments, latrine upgrades to a dual pit latrine Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on the use of latrines for defecation and the removal of human and animal feces from the compound. | Behavioural | Sanitation |
| Hand washingHardware: Hand washing stations, soapy water bottles located at hand washing locations, detergent soap to supply soapy water bottles. Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on hand washing with soap at critical times around food preparation, defecation, and contact with feces. | Behavioural | Hand washing |
| Water quality, Sanitation, Hand washing (Combined WASH)Hardware: Free supplies Aquatabs; (NaDCC) and a safe storage vessel to treat and store drinking water. Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on the treatment of drinking water for children < 36 months. Hardware: Free child potties, sani-scoop hoes to remove feces from household environments, latrine upgrades to a dual pit latrine. Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on the use of latrines for defecation and the removal of human and animal feces from the compound. Hardware: Hand washing stations, soapy water bottles, detergent soap to supply soapy water bottles. Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on hand washing with soap at critical times as food preparation, defecation, and contact with feces. | Behavioural | Combined WASH |
| NutritionSupplement: Lipid-based Nutrient Supplement (LNS) delivered daily from ages 6 to 24 months. Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages modeled on those recommended in the Guiding Principles for Complementary Feeding of the Breastfed Child and the recent UNICEF Program Guide for Infant and Young Child Feeding Practices.General messages will include (1) practice exclusive breastfeeding from birth to 6 months of age and introduce complementary foods at 6 months of age while continuing to breastfeed; (2) continue breast feeding as you did before receiving LNS; (3) provide your child micronutrient-rich foods such as meat, fish, eggs, and vitamin A rich fruits and vegetables; and (4) feed your child at least 2-3 times per day when 6-8 months old and 3-4 times per day when 9-24 months old. | Behavioural | Nutrition |
| Nutrition, Water quality, Sanitation, Hand washingEach of the interventions described above for Water Quality, Sanitation \& Hand washing (Combined WASH) Plus the intervention described above for nutrition. | Behavioural | Nutrition+ Combined WASH |
Primary outcome
Weschler Primary and Preschool Scales of Development 4th edition (WPPSI-IV)
Time frame: 5 years after intervention completion
The WPPSI-IV assessment measures cognitive development and general intellectual abilities in children 2 years 6 months to 7 years 7 months of age (2:6-7:7), and includes assessments of both performance and verbal skills.
Executive Functioning
Time frame: 5 years after intervention completion
This executive functioning assessment consists of three sub-scales to assess executive functioning in children including verbal memory, visual and non-verbal memory, and memory capacity.
Child Socioemotional Development
Time frame: 5 years after intervention completion
Maternal-report questionnaire designed to measure psychological adjustment in children and aims to detect any emotional or behavioural problems.
Fine Motor Development
Time frame: 5 years after intervention completion
Manual Dexterity component of Movement Assessment Battery for Children-2 (MABC-2) is a direct assessment tool used to measure fine motor skills in children 3 to 17 years of age.
Academic achievement
Time frame: 5 years after intervention completion
The Wide Range Assessment Test (WRAT) assessment is a written and verbal assessment of reading, writing, and math achievement.
5 secondary outcomes
Maternal Mental Health
Time frame: 5 years after intervention completion
Home environment
Time frame: 5 years after intervention completion
School attendance
Time frame: 5 years after intervention completion
Height-for-Age Z-scores
Time frame: 5 years after intervention completion
Weight-for-Height Z-scores
Time frame: 5 years after intervention completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Derived from this study: PubMed 41401135Tofail F, Pitchik HO, Islam M, Khan R, Shoab AK, Akter F, Aktar S, Huda TMN, Rahman M, Winch PJ, Luby SP, Fernald LCH. Effects of early water, sanitation, handwashing, and nutrition interventions on child development at school age: a follow-on study of a cluster-randomized trial in rural Bangladesh. PLoS Med. 2025 Dec 16;22(12):e1004793. doi: 10.1371/journal.pmed.1004793. eCollection 2025 Dec.
- Individual participant dataSharing planned: No. We will follow as per icddr,b data sharing policy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahbubur Rahman, MD principal investigator
International Centre for Diarrhoeal Disease Research, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water quality, Sanitation and Hand washing in people with Child Development and Maternal Depression, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahbubur Rahman, MD (+880-2-9827001-10 ext. 4003, mahbubr@icddrb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weschler Primary and Preschool Scales of Development 4th edition (WPPSI-IV) (time frame: 5 years after intervention completion). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04443855, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.